FDA Bans Lead-Based Neurotoxin from Consumer Hair Dyes

WASHINGTON – The Food and Drug Administration will ban the use of toxic lead acetate in consumer hair dyes such as Grecian Formula, the agency announced today. Lead acetate is the active ingredient that slowly darkens gray hair when used every few days, and can increase the level of lead in users’ bodies.

“A ban on lead acetate in off-the-shelf hair dyes is long overdue,” said Melanie Benesh, a legislative attorney at EWG, one of a dozen public interest groups and individuals who petitioned the FDA for the ban. “There is no safe level of lead exposure, which has been linked to developmental issues, reduced fertility, organ system toxicity, cancer and other serious health problems. We welcome the FDA’s effort to protect public health from this source of exposure to one of the most hazardous chemicals known.”

Scott Faber, EWG’s senior vice president for government affairs, said that although the decision was good news, it also shows that the federal system regulating cosmetics safety is badly broken.

“The fact is that personal care products are largely unregulated in the U.S.,” said Faber. “The federal law designed to ensure that personal care products are safe has remained largely unchanged since 1938, and the FDA does not even require safety testing of ingredients in personal care products before they are used. It’s an outrage that the agency has to be forced to ban something as dangerous as lead from a product you put on your scalp.”

In 1980, the FDA approved lead acetate as a repeated-use hair dye with minimal restrictions, including a warning label and a restriction that it only be used on the scalp, not on facial hair. The levels of lead in the product are allowed to be as high as 6,000 parts per million, or ppm. Three years earlier, the Consumer Product Safety Commission banned the sale of household paint containing more than 600 ppm of lead.

The petition was filed in February 2017 by EWG, Environmental Defense Fund, Earthjustice, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Natural Resources Defense Council, Improving Kids’ Environment, Consumers Union and Howard Mielke, a lead expert who is a research professor at the Tulane School of Medicine. The petitioners cited major advances in science since the 1980 FDA decision allowing lead to remain in hair dye.

Cosmetics are a $60 billion-a-year business, and no other products are so widely used by American consumers with such few safeguards. A bipartisan bill introduced by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, would require companies to ensure products are safe before placing them on the market and finally give the FDA the same tools for ensuring the safety of personal care products as it now uses to regulate food and drugs.

The agency will enforce this new lead acetate ban in 12 months, which will give companies time to reformulate and remove the color additive. Lead acetate has been banned in Canada and the European Union.

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The Environmental Working Group is a non-profit, non-partisan organization that empowers people to live healthier lives in a healthier environment. Through research, advocacy and unique education tools, EWG drives consumer choice and civic action.